Oral composition comprising isomalt and remineralizing enhancing agent

ABSTRACT

Disclosed is an oral composition comprising palatinit. More particularly, disclosed is an oral composition comprising palatinit which exerts a synergistic effect when combined with a fluorine or zinc compound.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of application Ser. No. 09/673,618,filed Oct. 19, 2000, now U.S. Pat. No. 6,471,946 which is a nationalphase application from PCT/JP99/02060, filed Apr. 19, 1999 and claimsthe benefit of priority under 35 U.S.C. § 119(e) of the aboveapplications and Japanese patent application nos. JP 131413, filed Apr.24, 1009, JP 373873, filed Dec. 28, 1998, and JP 107809, filed Apr. 15,1999, the disclosures of which are incorporated herein in theirentirety.

FIELD OF THE INVENTION

The present invention relates to an oral composition comprisingpalatinit, and more particularly, it relates to an oral compositioncomprising palatinit which exhibits the synergistic effect when combinedwith a fluorine or zinc compound.

BACKGROUND OF THE INVENTION

Dental caries is a state of a dental carious cavity caused by thedissolution of calcium from teeth and which can not naturally return toa healthy state. But, there is a state referred to as a sub-surfacelesion which can return to the healthy state, in the course of thedevelopment of the dental carious cavity (“Zusetsu Ushoku-gaku” editedby Shoichi, Suga, 1990, 139). Therefore, in order to decrease dentalcaries, it is desirable to enhance the remineralization so that theteeth can return to the healthy state within a term during which theteeth return to the original state.

As a method for enhancing the remineralization, the use of fluorinecompounds has been known for a long time. However, because the ingestionof a large amount of fluorine exhibits the toxicity, it is desired thatfluorine be effectively utilized in an as smaller as possible amount. Toaccomplish this, the use of a substance that enhances theremineralization effect of fluorine is exemplified. For example, thereis proposed a combination of fluorine and hydroxy-apatite inJP-A-1-110608. However, its effect is insufficient and is notsatisfactory.

On the other hand, a zinc compound that has been utilized in the oralcomposition generally has an astringent or salty taste and, therefore,there is a problem that it has the very bad feeling for use upon itsuse.

One object of the present invention is to provide an oral compositionwhich has the high safety and can enhance the remineralization. Anotherobject of the present invention is to provide an oral composition whichexhibits the sufficient remineralization effect and has the betterfeeling for use.

SUMMARY OF THE INVENTION

In view of the above circumstances, the present inventors studiedintensively the substances that can enhance the remineralization and, asa result, found that palatinit exhibits the excellent properties, thatan oral composition comprising palatinit can enhance theremineralization, and, further, that the inclusion of palatinit in acombination with a fluorine or zinc compound can enhance theremineralization due to the synergistic effect of both ingredients,which resulted in the completion of the present invention.

Palatinit has hitherto been utilized in foods and the like as a lowcariogenic sweetener. However, palatinit has never been utilized for anoral-use, and its remineralization effect is not known.

That is, the present invention has completed based on such novelfindings, and, in the first aspect, provides an oral compositioncomprising palatinit which has the high safety and can enhance theremineralization.

Moreover, in the second aspect, the present invention provides an oralcomposition comprising palatinit and a remineralization enhancingingredient, which exhibits the sufficient remineralization effect andhas the better feeling for use.

The present invention is described below in detail according to thefirst and second aspects thereof in sequence.

[First Aspect]

Palatinit to be used in the first and second aspects of the presentinvention is a sugar alcohol of a disaccharide, and may beα-D-glucopyranosyl-1,6-mannitol, its isomer,α-D-glucopyranosyl-1,6-sorbitol or a mixture thereof. Palatinit can beobtained by hydrogenation of palatinose which is converted from sucroseas a raw material with glycosyltransferase. And, palatinit is also atrade name of the product of Mitsui Sugar Co. Ltd. or Sudzucker A. G.,and is also referred to as reduced-palatinose or isomalt. Palatinit iswidely known as a non-cariogenic sugar which scarcely develops dentalcaries, based on the fact that the cariogenic microorganisms do notproduce acids from palatinit in an oral cavity. Palatinit has beenblended in non-sugar foods or a specified health food such as so-called“dental caries-resistant candy”.

The amount of palatinit to be blended in the present oral composition isin the range of 0.1% to 60% by weight, preferably 1% to 40% by weight,based on the total weight of the oral composition. When the amount isless than 0.1% by weight, the desired effect can not be obtained. On theother hand, when the amount is more than 60% by weight, the stability ofthe formulation is deteriorated.

[Second Aspect]

The remineralization enhancing ingredient to be used in the secondaspect of the present invention is an ingredient which can remineralizethe teeth from its sub-surface lesion state. Examples of theremineralization enhancing ingredient are fluorine compounds, zinccompounds, phosphorus compounds, calcium compounds and the like, but notlimited thereto.

Examples of the fluorine compound to be used in the second aspect of thepresent invention as the remineralization enhancing ingredient aresodium fluoride, potassium fluoride, ammonium fluoride, stannousfluoride, sodium or potassium monofluorophosphate and the like.Particularly preferred are sodium fluoride and sodiummonofluorophosphate.

These fluorine compounds, alone or in a combination thereof, may beblended in the present oral composition in the range of 0.1-5,000 ppm,preferably 100-1,100 ppm in terms of fluoride ion, based on the totalweight of the present oral composition.

Further, the zinc compound to be used in the second aspect of thepresent invention as the remineralization enhancing ingredient ispreferably a water-slightly soluble zinc compound, wherein thewater-slightly soluble zinc compound is defined as having the solubilityof less than 0.5 g per 100 g of water at 25, and water-insoluble zinccompound is included therein. Among them, particularly preferred arezinc oxide, zinc citrate and zinc stearate. From a viewpoint of a taste,the water-slightly soluble zinc compound having a smaller particlediameter and a greater specific surface area is preferred. Moreparticularly, preferred are those having the particle diameter of notgreater than 0.3 μm and the specific surface area of greater than 10m²/g. When the particle diameter exceeds 0.3 μm, the astringency becomesstrong. Examples of the commercial products of the zinc compound arefine particle zinc white and hyperfine particle zinc oxide, “FINEXseries” manufactured by Sakai Chemical Industry Co., Ltd. Thesewater-slightly soluble zinc compounds, alone or in a combinationthereof, may be blended in the oral composition in the amount of 0.1% to5% by weight, based on the total weight of the present oral composition.

Further, when the oral composition of the second aspect of the presentinvention contains a zinc compound, preferred pH thereof is within therange of 6.0 to 8.5. When pH is lower than 6.0, then the astringency isstrong, and when pH is higher than 8.5, then oral mucosa may beirritated, therefore, the composition out of the above pH range is notpreferable.

Further, examples of the phosphorus compound to be used in the secondaspect of the present invention as the remineralization enhancingingredient are disodium hydrogenphosphate, sodium dihydrogenphosphate,dipotassium hydrogenphosphate, potassium dihydrogenphosphate, trisodiumphosphate, tripotassium phosphate and the like, but not limited thereto.

Moreover, examples of the calcium compound to be used in the secondaspect of the present invention as the remineralization enhancingingredient are, for example, calcium chloride, calcium nitrate, calciumsulfate, calcium carbonate, calcium citrate, calciumhydrogenpyrophosphate, calcium gluconate, calcium glycerophosphate,calcium hydroxide, calcium oxide, calcium silicate and the like, but notlimited thereto.

That is, the present invention provides an oral composition comprisingpalatinit alone or in a combination with any remineralization enhancingingredients, which can enhance the remineralization due to thesynergistic effect of both ingredients.

The oral composition of the present invention may be properlyformulated, depending upon its use, into a form such as a toothpaste,powder or liquid dentifrice, wetting dentifrice, gel, cream, pasta,mouthwash, spray, foam, coating agent and the like, according to theconventional procedure. Other ingredients to be blended therein are notparticularly limited, and the known active ingredients, polishingagents, humectants, thickening agents, foaming agents, preservatives,flavoring agents, sweeteners, pH adjusting agents, organic acids, sugaralcohol, anti-oxidizing agents and others known as the ingredient forthe oral composition may be blended in the oral composition, so long asthey do not deteriorate the effects of the present invention.

Examples of the active ingredient are enzymes such as amylase, protease,lysozyme and dextranase, the antimicrobial agents such as sanguinarine,allantoin, aminobenzoate derivatives, hexetidine, chlorhexidine,triclosan and cetylpyridinium chloride, vitamins such as vitamin B, Cand E, and the astringents such as potassium nitrate, lithium nitrateand sodium nitrate.

Examples of the polishing agent are silica, alumina, aluminosilicate,aluminium hydroxide and the like.

Examples of the humectant are glycerol, propylene glycol, sorbitol,polyethylene glycol, polypropylene glycol and the like.

Examples of the thickening agent are sodium carboxymethyl cellulose,methyl cellulose, hydroxyethyl cellulose, alginates, xanthan gum,carrageenan, gum arabic, polyvinyl alcohol and the like.

Examples of the forming agent are anionic-, nonionic-, cationic- andamphoteric-surfactants. Examples of the anionic-surfactant are alkylsulfates, sodium dodecylbenzene sulfonate, amino acids, sulfosuccinates,sucrose fatty acid esters and the like. Examples of thenonionic-surfactant are Pluronic series that arepolyoxyethylene-polyoxypropylene copolymer, fatty acid dialkanolamidesand the like.

Examples of the preservative are methylparaben, propylparaben,benzoates, sodium benzoate, paraoxybenzoic acid esters, titanium dioxideand the like.

Examples of the flavoring agent are peppermint oil, spearmint oil,Japanese peppermint oil, orange oil, menthol, cloves oil, anise oil,wintergreen oil, eucalyptus oil and the like.

Examples of the sweetening agent or sweetener are saccharin salts,dextrose, Aspartame, xylitol, stevia extract, Acesulfame, granulatedsugar, powdered sugar, starch syrup and the like. Although palatinitexhibits sweetness, the above sweetening agents or sweeteners may beadded depending upon the feeling for use of the formulation.

Examples of the pH adjusting agent are citric acid and salts thereof,phosphoric acid and salts thereof, malic acid and salts thereof,gluconic acid and salts thereof, maleic acid and salts thereof, asparticacid and salts thereof, gluconic acid and salts thereof, succinic acidand salts thereof, glucuronic acid and salts thereof, fumaric acid andsalts thereof, glutamic acid and salts thereof, adipic acid and saltsthereof, lactic acid and salts thereof, pantothenic acid and saltsthereof, hydrochloric acid, alkali metal hydroxides and the like.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a graph which compares the remineralization effects of thevarious sugars in the system not containing fluoride.

FIG. 2 is a graph which compares the remineralization effects of thevarious sugars in the system containing fluoride.

DETAILED DESCRIPTION OF THE INVENTION

The present invention will be further illustrated by way of thefollowing Examples, which are not to be construed to limit the scope ofthe present invention. The amounts indicated in the Examples are allpercents (%) by weight.

EXPERIMENTAL EXAMPLE 1

Evaluation of the Remineralizing Ability 1

The remineralization effect of the sugars was evaluated in an in vitrotest using a bovine tooth according to the procedures described in D. J.White et al., Caries Res., 21, 228 (1987).

1. An enamel section having 4 mm length×3 mm width was obtained from thebovine tooth. The section was embedded in a dental resin to obtain anenamel block.

2. An enamel varnish was applied to a portion of approximately ⅓ of thesurface of the enamel block in order not to cause the demineralizationof that portion. Then, the enamel block was demineralized with ademineralizing solution containing 50% of saturated hydroxyapatite/0.1Mlactic acid/pH 5.0 to prepare an artificial caries.

3. An enamel varnish was applied to a portion of approximately ⅔ of thesurface of the treated enamel block in order not to cause theremineralization of that portion. The enamel block was immersed for tendays in a test solution prepared by adding the test sugar into anaqueous solution containing 3.0 mM calcium ion and 1.8 mM phosphate ionso that the concentration of the sugar became 20%, to perform theremineralization treatment.

4. Three thin sections having approximately 500 μm in thickness wereprepared from the enamel block. The central portion of the thin sectionswas ground so that the thickness became approximately 100 μm using adouble-side polishing machine.

5. The X-ray photograph was taken of the thin section prepared in thefourth step. The mineral amounts of the demineralized portion and theremineralized portion were calculated based on the brightness of theeach portion and a distance from the surface using an image processor.The mineral amount difference between the demineralized andremineralized portions was expressed as a remineralization value. Agreater value thereof shows the greater remineralization. A control testwas performed in a similar manner to that described above, except thatthe test solution containing only 3.0 mM calcium ion and 1.8 mMphosphate ion but not containing the sugar was used. The results areshown in Table 1 and FIG. 1.

TABLE 1 Systems not containing fluoride Sugar (20%) Remineralizationvalue Control 405 Sorbitol 645 Mannitol 640 Xylitol 416 Erythritol 602Trehalose 715 Palatinit 1057 Unit: Vol. % μm

Further, a similar test was performed in which sodium fluoride was addedto the test solution to 2 ppm in terms of fluoride ion. The results areshown in Table 2 and FIG. 2.

TABLE 2 Systems containing fluoride (2 ppm) Sugar (20%) Remineralizationvalue Control 1626 Sorbitol 1358 Mannitol 1377 Xylitol 1636 Erythritol1330 Trehalose 1205 Palatinit 2374 Unit: Vol. % μm

From Tables 1 and 2, it was found that, among the sugars tested,palatinit has the particularly excellent remineralizing ability and thatthe remineralizing ability is enhanced by combining palatinit withsodium fluoride.

EXPERIMENTAL EXAMPLE 2

Evaluation of the Remineralizing Ability 2

The remineralization enhancing effects of the oral compositions to whichthe various sugars had been added were tested in vitro according to thesimilar manner to that described in Experimental Example 1.

Provided that, in the remineralization treatment, a solution containing3.0 mM calcium ion and 1.8 mM phosphate ion to which a test dentifrice(see Table 3) had been added as to form a 4-fold slurry was used, andthe immersion period was set to be fourteen days. The results of theX-ray photograph were evaluated using the image processor according to asimilar manner to that described in Experimental Example 1. The resultsare shown in Table 3.

TABLE 3 Compara- Compara- Compara- Compara- Compara- tive tive tive tivetive Ingredients Example 1 Example 2 Example 3 Example 4 Example 5Example 6 Example 1 Example 2 Example 3 Example 4 Example 5 Silicic acid20 20 20 20 20 20 20 20 20 20 20 anhydride Sodium 1.5 1.5 1.5 1.5 1.51.5 1.5 1.5 1.5 1.5 1.5 carboxymethyl cellulose Sorbitol 40 40 35 25 1515 45 45 35 35 35 Sodium lauryl 1.5 1.5 1.5 1.5 1.5 1.5 1.5 1.5 1.5 1.51.5 sulfate Saccharin 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 sodiumSodium fluoride — 0.2 0.2 0.2 0.2 0.2 — 0.2 0.2 0.2 0.2 Flavor 1 1 1 1 11 1 1 1 1 1 Xylitol — — — — — — — — 10 — — Erythritol — — — — — — — — —10 — Trehalose — — — — — — — — — — 10 Palatinit 10 5 10 20 30 60 — — — —— Remineralization 852 1328 1468 1496 1548 1580 320 1024 958 842 862value

From the above Table 3, it was found that palatinit has the particularlyexcellent remineralizing ability, also in the evaluation of Examples 1-6and Comparative Examples 1-5.

EXPERIMENTAL EXAMPLE 3

Evaluation of the Remineralizing Ability 3

The remineralization enhancing effect of the oral composition to whichthe zinc compound had been added was tested in vitro according to almostthe same manner as that described in Experimental Example 1.

Provided that, in the remineralization treatment, a solution containing3.0 mM calcium ion and 1.8 mM phosphate ion to which the test dentifrice(see Table 4) had been added so as to form a 4-fold slurry was used, andthe pH cycling procedure was taken in which the enamel block wasadditionally immersed in the demineralization solution for three hoursper day. An evaluation period was set to be fourteen days. The resultsof the X-ray photograph were evaluated using the image processoraccording to a similar manner to that described in ExperimentalExample 1. The results are shown in Table 4.

TABLE 4 Comparative Comparative Ingredients Example 7 Example 8 Example9 Example 10 Example 11 Example 12 Example 13 Example 6 Example 7Silicic acid anhydride 20 20 20 20 20 20 20 20 20 Sodium 1.5 1.5 1.5 1.51.5 1.5 1.5 1.5 1.5 carboxymethyl cellulose Sorbitol 40 40 35 25 35 3535 50 35 Sodium lauryl sulfate 1.5 1.5 1.5 1.5 1.5 1.5 1.5 1.5 1.5Saccharin sodium 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 Sodium fluoride —0.2 0.2 0.2 0.2 0.2 0.2 — 0.2 Flavor 1 1 1 1 1 1 1 1 1 Xylitol — — — — —— — — 10 Palatinit 10 10 10 20 10 10 10 — — Zinc oxide 1 — 1 — — 0.1 5 1— Zinc stearate — — — 1 — — — — — Zinc citrate — — — — 1 — — — —Remineralization value 102 513 542 516 630 530 721 10 354

From the above Table 4, in the evaluation of Examples 7-13 andComparative Examples 6-7, it was shown that the remineralization isenhanced by blending palatinit and a zinc compound.

EXPERIMENTAL EXAMPLE 4

Organoleptic Evaluation of the Astringency 1

The oral compositions of Examples 14-16 and Comparative Examples 8-9 inTable 5 were prepared. Ten healthy persons used these oral compositionsaccording to the conventional manner, and the astringency after spoutwas organoleptically evaluated. The total points of ten healthy personsare shown according to the following 3 grades—criteria: 2: excellent; 1:good; 0: astringent. The results are shown in Table 5.

TABLE 5 Comparative Comparative Ingredients Example 14 Example 15Example 16 Example 8 Example 9 Silicic acid 20 20 20 20 20 anhydrideSodium  1.5  1.5  1.5  1.5  1.5 carboxymethyl cellulose Sorbitol 35 3535 35 35 Sodium lauryl  1.5  1.5  1.5  1.5  1.5 sulfate Saccharin sodium 0.1  0.1  0.1  0.1  0.1 Sodium fluoride  0.2*  0.2  0.2  0.2  0.2Flavor  1  1  1  1  1 Zinc oxide 1  1 — —  1 — Zinc oxide 2 —  1 — — —Zinc oxide 3 — —  1 —  1 Palatinit 10 10 10 — — Total point 15 17 17  0 2 *The concentration in terms of fluoride ion is 905 ppm. Zinc oxide 1:The average particle diameter is 0.5 μm and the specific surface area is8 m²/g. Zinc oxide 2: The average particle diameter is 0.28 μm and thespecific surface area is 10 m²/g. Zinc oxide 3: The average particlediameter is 0.04 μm and the specific surface area is 25 m²/g.

From the above Table 5, it was found that the astringency can beimproved by decreasing the average particle diameter of zinc oxide orincreasing the specific surface area thereof, and can be furtherimproved by combining with palatinit.

EXPERIMENTAL EXAMPLE 5

Organoleptic Evaluation of the Astringency 2

The oral compositions of Examples 17-18 and Comparative Example 10having the varied pH values were prepared, and evaluated according to asimilar manner to that described above. The results are shown in Table6.

TABLE 6 Comparative Ingredients Example 17 Example 18 Example 10 Silicicacid anhydride 20 20 20 Sodium carboxymethyl 1.5 1.5 1.5 celluloseSorbitol 35 35 35 Sodium lauryl sulfate 1.5 1.5 1.5 Saccharin sodium 0.10.1 0.1 Sodium fluoride 0.2 0.2 0.2 Flavor 1 1 1 Zinc oxide 2* 1 1 1Palatinit 10 10 10 Disodium 0.1 0.1 0.1 hydrogenphosphate Sodium 0.250.2 0.3 dihydrogenphosphate pH 6.0 7.0 5.0 Total point 16 17 10 *Theaverage particle diameter is 0.28 μm and the specific surface area is 10m²/g.

From the above Table 6, it was shown that the astringency can beimproved by adjusting pH of the oral composition to 6.0 or higher.

EXAMPLE 19 TOOTHPASTE

A toothpaste was prepared by the following formulation according to theconventional procedures.

Ingredients Amounts % Palatinit 10.0 Sodium fluoride 0.2 (Theconcentration in terms of fluoride ion is 905 ppm) Silicic acidanhydride 16.0 Sodium carboxymethyl cellulose 1.3 Sodium lauryl sulfate1.0 Titanium dioxide 0.4 Paraoxybenzoic acid ester 0.1 Citric acid 0.1Trisodium citrate 0.3 Saccharin sodium 0.1 Flavor 0.6 Sorbitol 50.0Purified water balance Total 100.0

EXAMPLE 20 TOOTHPASTE

A toothpaste was prepared by the following formulation according to theconventional procedures.

Ingredients Amounts % Palatinit 30.0 Silicic acid anhydride 20.0 Sodiumcarboxymethyl cellulose 1.2 Sodium lauryl sulfate 1.2 Titanium dioxide0.3 Hydrochloric acid 0.5 Saccharin sodium 0.13 Sorbitol 10.0 Flavor 1.0Purified water balance Total 100.0

EXAMPLE 21 TOOTHPASTE

A toothpaste was prepared by the following formulation according to theconventional procedures.

Ingredients Amounts % Palatinit 50.0 Sodium fluoride 0.2 (Theconcentration in terms of fluoride ion is 905 ppm) Silicic acidanhydride 16.0 Carrageenan 1.3 Sodium lauryl sulfate 3.5 Titaniumdioxide 0.4 Paraben 0.1 Xylitol 10.0 Flavor 0.7 Glycerol 5.0 Purifiedwater balance Total 100.0

EXAMPLE 22 TOOTHPASTE

A toothpaste was prepared by the following formulation according to theconventional procedures.

Ingredients Amounts % Palatinit 15.0 Sodium monofluorophosphate 0.76(The concentration in terms of fluoride ion is 950 ppm) Calciumcarbonate 16.0 Sodium carboxymethyl cellulose 1.3 Sodiumlauroylsarcosinate 2.0 Polyoxyethylene hydrogenated castor oil 1.0Titanium dioxide 0.4 Paraoxybenzoic acid ester 0.1 Malic acid 0.2 Steviaextract 0.1 Flavor 0.7 Sorbitol 40.0 Polyethylene glycol 5.0 Purifiedwater balance Total 100.0

EXAMPLE 23 TOOTHPASTE

A toothpaste was prepared by the following formulation according to theconventional procedures.

Ingredients Amounts % Palatinit 5.0 Sodium fluoride 0.21 (Theconcentration in terms of fluoride ion is 950 ppm) Triclosan 0.5 Silicicacid anhydride 16.0 Sodium polyacrylate 2.0 Sodium lauryl sulfate 1.0Pluronic 1.0 Titanium dioxide 0.4 Paraoxybenzoic acid ester 0.1 Xylitol10.0 Flavor 0.7 Sorbitol 50.0 Purified water balance Total 100.0

EXAMPLE 24 MOUTHWASH

A mouthwash was prepared by the following formulation according to theconventional procedures.

Ingredients Amounts % Palatinit 10.0 Sodium fluoride 0.05 (Theconcentration in terms of fluoride ion is 225 ppm) Sodium lauryl sulfate0.5 Polyoxyethylene hydrogenated castor oil 1.0 Sodiumdihydrogenphosphate 0.1 Disodium hydrogenphophate 0.1 Saccharin sodium0.1 Flavor 0.7 Ethanol 10.0 Glycerol 10.0 Purified water balance Total100.0

EXAMPLE 25 MOUTHWASH

A mouthwash was prepared by the following formulation according to theconventional procedures.

Ingredients Amounts % Palatinit 30.0 Polyoxyethylene hydrogenated castoroil 1.0 Sodium citrate 0.2 Citric acid anhydride 0.2 Flavor 0.8 Glycerol10.0 Purified water balance Total 100.0

EXAMPLE 26 MOUTHWASH

A mouthwash was prepared by the following formulation according to theconventional procedures.

Ingredients Amounts % Palatinit 10.0 Sodium fluoride 0.05 (Theconcentration in terms of fluoride ion is 225 ppm) Sodium lauryl sulfate0.2 Polyoxyethylene (2)-synthetic C₁₂, C₁₄ alkyl- sodium sulfosuccinate0.2 Malic acid 0.3 Flavor 0.7 Glycerol 10.0 Xylitol 5.0 Purified waterbalance Total 100.0

EXAMPLE 27 GEL DENTIFRICE

A gel dentifrice was prepared by the following formulation according tothe conventional procedures.

Ingredients Amounts % Palatinit 10.0 Hydroxyethyl cellulose 3.0 Sodiumfluoride 1.0 (The concentration in terms of fluoride ion is 4,500 ppm)Phosphoric acid 3.0 Saccharin sodium 0.5 Flavor 0.8 Glycerol 20.0Purified water balance Total 100.0

EXAMPLE 28 NON AEROSOL-TYPE FOAM DENTIFRICE

A non aerosol-type foam dentifrice was prepared by the followingformulation according to the conventional procedures.

Ingredients Amounts % Palatinit 5.0 Sodium fluoride 1.0 (Theconcentration in terms of fluoride ion is 4,500 ppm) Phosphoric acid 3.0Tripotassium phosphate trihydrate 1.5 Sodium lauryl sulfate 1.0 Pluronic7.0 Coconut oil fatty acid diethanolamide 0.5 Saccharin sodium 0.8Flavor 0.7 Ethanol 5.0 Purified water balance Total 100.0

EXAMPLE 29 ORAL GEL

An oral gel was prepared by the following formulation according to theconventional procedures.

Ingredients Amounts % Palatinit 20.0 Carboxymethyl cellulose 0.2Glycerol 40.0 Grape seed extract 1.0 α-tocopherol 0.05 Purified waterbalance Total 100.0

EXAMPLE 30 TOOTHPASTE

A toothpaste was prepared by the following formulation according to theconventional procedures.

Ingredients Amounts % Palatinit 10.0 Sodium fluoride 0.21 (Theconcentration in terms of fluoride ion is 950 ppm) Silicic acidanhydride 21.0 Sodium carboxymethyl cellulose 1.1 Sodium lauryl sulfate0.5 Sodium lauroylsarcosinate 0.1 Titanium dioxide 0.3 Fine particlezinc oxide 1.0 (The average particle diameter is 0.3 μm: the specificsurface area is 10 m²/g) Paraoxybenzoic acid ester 0.1 Saccharin sodium0.1 Flavor 0.7 Xylitol 1.0 Sorbitol 38.0 Hydrochloric acid (2N) 1.0Purified water balance Total 100.0 pH 6.5

EXAMPLE 31 TOOTHPASTE

A toothpaste was prepared by the following formulation according to theconventional procedures.

Ingredients Amounts % Palatinit 50.0 Zinc stearate 1.0 Sodium fluoride0.21 (The concentration in terms of fluoride ion is 950 ppm) Silicicacid anhydride 16.0 Carrageenan 1.3 Sodium lauryl sulfate 3.5 Titaniumdioxide 0.4 Paraben 0.1 Xylitol 10.0 Flavor 0.7 Glycerol 5.0 Purifiedwater balance Total 100.0 pH 7.0

EXAMPLE 32 TOOTHPASTE

A toothpaste was prepared by the following formulation according to theconventional procedures.

Ingredients Amounts % Palatinit 15.0 Zinc citrate 0.5 Sodiummonofluorophosphate 0.75 (The concentration in terms of fluoride ion is950 ppm) Calcium carbonate 16.0 Sodium carboxymethyl cellulose 1.3Sodium lauroylsarcosinate 2.0 Polyoxyethylene hydrogenated castor oil1.0 Titanium dioxide 0.4 Paraoxybenzoic acid ester 0.1 Malic acid 0.2Stevia extract 0.1 Flavor 0.7 Sorbitol 40.0 Polyethylene glycol 5.0Purified water balance Total 100.0 pH 7.5

EXAMPLE 33 TOOTHPASTE

A toothpaste was prepared by the following formulation according to theconventional procedures.

Ingredients Amounts % Palatinit 5.0 Fine particle zinc oxide 1.5 (Theaverage particle diameter is 0.3 μm: the specific surface area is 10m²/g.) Sodium fluoride 0.21 (The concentration in terms of fluoride ionis 950 ppm) Triclosan 0.5 Silicic acid anhydride 16.0 Sodiumpolyacrylate 2.0 Sodium lauryl sulfate 1.0 Pluronic 1.0 Titanium dioxide0.4 Paraoxybenzoic acid ester 0.1 Xylitol 10.0 Flavor 0.7 Sorbitol 50.0Hydrochloric acid (1N) 1.5 Purified water balance Total 100.0 pH 6.8

EXAMPLE 34 MOUTHWASH

A mouthwash was prepared by the following formulation according to theconventional procedures.

Ingredients Amounts % Palatinit 10.0 Zinc citrate 0.1 Sodium fluoride0.05 (The concentration in terms of fluoride ion is 225 ppm) Sodiumlauryl sulfate 0.5 Polyoxyethylene hydrogenated castor oil 1.0 Sodiumdihydrogenphosphate 0.1 Disodium hydrogenphophate 0.1 Saccharin sodium0.1 Flavor 0.7 Ethanol 10.0 Glycerol 10.0 Purified water balance Total100.0 pH 6.0

EXAMPLE 35 MOUTHWASH

A mouthwash was prepared by the following formulation according to theconventional procedures.

Ingredients Amounts % Palatinit 10.0 Fine particle zinc oxide 0.1 (Theaverage particle diameter is 0.3 μm: the specific surface area is 10m²/g) Sodium fluoride 0.05 (The concentration in terms of fluoride ionis 225 ppm) Sodium lauryl sulfate 0.2 Polyoxyethylene (2)-synthetic C₁₂,C₁₄ alkyl- 0.2 sodium sulfosuccinate Malic acid 0.3 Flavor 0.7 Glycerol10.0 Xylitol 5.0 Purified water balance Total 100.0 pH 7.5

EXAMPLE 36 GEL DENTIFRICE

A gel dentifrice was prepared by the following formulation according tothe conventional procedures.

Ingredients Amounts % Palatinit 10.0 Fine particle zinc oxide 0.1 (Theaverage particle diameter is 0.3 μm: the specific surface area is 10m²/g) Sodium fluoride 1.0 (The concentration in terms of fluoride ion is4,500 ppm) Phosphoric acid 3.0 Saccharin sodium 0.5 Flavor 0.8 Glycerol20.0 Hydrochloric acid (2N) 1.0 Purified water balance Total 100.0 pH6.9

EXAMPLE 37 ORAL GEL

An oral gel was prepared by the following formulation according to theconventional procedures.

Ingredients Amounts % Palatinit 20.0 Carboxymethyl cellulose 0.2 Fineparticle zinc oxide 0.1 (The average particle diameter is 0.3 μm: thespecific surface area is 10 m²/g) Glycerol 40.0 Grape seed extract 1.0α-tocopherol 0.05 Purified water balance Total 100.0 pH 8.5

The present invention relates to an oral composition, which has the highsafety, comprising either palatinit alone or in combination withfluorine compound, as well as an oral composition comprising palatinitin combination with zinc compound, which improves a bad feeling for usedue to the zinc compound, and, by the inclusion of said ingredient, thepresent invention can provide an oral composition which can enhanceremineralization.

1. An oral composition for remineralization selected from the groupconsisting of a toothpaste, liquid dentifrice, gel, cream, mouthwash,spray, and foam comprising a combination of isomalt present in an amountof 0.1% to 60% of the total weight of the composition and aremineralization enhancing ingredient, wherein said remineralizationenhancing ingredient is (A) a fluorine compound present in an amount of100-1,100 ppm in terms of fluoride ion based on the total weight of thecomposition or (B) a water-slightly soluble zinc compound selected fromthe group consisting of zinc oxide, zinc citrate and zinc stearate thatpresent in an amount of 0.1% to 5% of the total weight of thecomposition, and water and wherein said isomalt and saidremineralization enhancing ingredient result in an increasedremineralization value in comparison to the same ingredients of thecomposition except without the presence of isomalt.
 2. The oralcomposition according to claim 1, comprising said fluorine compound as aremineralization enhancing ingredient.
 3. The oral composition accordingto claim 2, wherein said fluorine compound is sodium fluoride.
 4. Theoral composition according to claim 1, comprising said water-slightlysoluble zinc compound as a remineralization enhancing ingredient.
 5. Theoral composition according to claim 4, wherein said water-slightlysoluble zinc compound is a powder having an average particle diameter ofnot greater than 0.3 μm and a specific surface area of greater than 10m²/g.
 6. The oral composition according to claim 4, which has pH of6.0-8.5.
 7. The oral composition according to claim 6, whereinhydrochloric acid is used as a pH adjusting agent.
 8. The oralcomposition according to claim 4, further comprising a fluorinecompound.
 9. The oral composition according to claim 8, wherein saidfluorine compound is sodium fluoride.
 10. A method of increasingremineralization in the teeth of a patient in need thereof comprisingorally administering a composition of claim 1 to said patient, whereinan increased remineralization value results in comparison toadministering the same ingredients of the composition except without thepresence of isomalt.
 11. A method of increasing remineralization in theteeth of a patient in need thereof comprising orally administering acomposition of claim 9 to said patient, wherein an increasedremineralization value results in comparison to the administering thesame ingredients of the composition except without the presence ofisomalt.
 12. The oral composition according to claim 5, furthercomprising a fluorine compound.
 13. The oral composition according toclaim 12, wherein said fluorine compound is sodium fluoride.